Diclac 23,3 mg/g gel 100g.

1. What Diklak 12 hours is and what it is used for

Diclak 12 hours contains the active ingredient diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Diklak 12 hours relieves pain and reduces inflammation in painful conditions affecting joints and muscles.

Diklak 12 hours can be used to treat the following disorders:

Adults and adolescents over 14 years of age

muscle and joint injuries (eg sprains, strains, back pain, sports injuries), reduces pain even in moderate to severe pain, improves patient mobility and helps return to normal daily activities

tendinitis (eg "tennis elbow"), swelling in the elbow and knee area

Adults (over 18 years)

mild forms of arthritis of the knees and fingers

If after 7 days you do not feel better or your condition worsens, you should seek medical attention.

2. What you need to know before you use Diklak 12 hours

Do not use Diklak for 12 hours

if you are allergic to

diclofenac,

other medicines used to treat pain, fever or inflammation such as ibuprofen or acetylsalicylic acid (a substance also used to prevent blood clotting) or

any of the other ingredients of this medicine (listed in section 6)

Symptoms of an allergic reaction may include: wheezing or shortness of breath (asthma; bronchospasm); skin rash with blisters or hives; swelling of the face, tongue, or throat; runny nose.

If you are not sure, consult your doctor or pharmacist.

on open wounds, inflammations or infections of the skin, as well as on eczema (dry, itchy skin) or mucous membranes

in the last three months of pregnancy

in children and adolescents under 14 years of age

Warnings and precautions

Talk to your doctor or pharmacist before using Diclak 12 hours.

Do not use Diklak 12h in larger doses and for a longer period of time, except on the express instructions of your doctor.

Apply Diklak for 12 hours only on healthy skin, without damage and wounds.

This medicine is for use on the skin only. Do not swallow it.

Avoid contact with eyes and mouth.

If it gets into the eyes, rinse them thoroughly with clean water. Consult your doctor if you continue to feel any discomfort.

After applying the gel to the skin, you can use an elastic (breathable) bandage, but before that, the gel must be allowed to dry for a few minutes on the skin. Do not use an impermeable occlusive (tight) dressing.

Stop using Diclak for 12 hours if a skin rash occurs.

Avoid sun exposure, including tanning beds, when using this medication.

Do not allow children to touch the area where the gel has been applied.

Be careful when smoking or near open flames because of the risk of serious burns. Diclak 12 hours contains paraffin, which is flammable when accumulated on fabrics (clothing, sheets, bandages, etc.) and cannot be completely removed by washing.

Children and adolescents

Diklak 12 hours is not recommended for children and adolescents under 14 years of age. There are insufficient data available on efficacy and safety in this age group (see also "Do not use Diclak 12 hours" above).

If adolescents aged 14 years and older need to use this medicine for pain relief for more than 7 days, or if symptoms worsen, it is recommended that patients or their parents consult a doctor.

Other medicines and Diklak 12 hours

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Currently, there are no known interactions when Diklak 12 hours is used as intended on the skin.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Do not use Diclax 12 hours during the last trimester of pregnancy, as this may harm your unborn child or cause complications during delivery.

During the first and second trimester of pregnancy, Diklak 12 hours should be used only after consultation with your doctor.

Breastfeeding

Diclak 12 hours should be used only after a doctor's recommendation during breastfeeding, as diclofenac passes in small amounts into breast milk. Do not apply Diklak 12 hours on the breast if you are breastfeeding, or anywhere else on large areas of skin and for a long period of time.

Driving and using machines

Diklak 12 hours has no or negligible influence on the ability to drive and use machines.

Diklak 12 hours contains butylhydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Diklak 12 hours

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure

and in anything, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 14 years old

Diklak 12 hours is used 2 times a day (preferably morning and evening), which provides long-lasting pain relief for up to 12 hours.

Depending on the area of ​​the affected area to be treated, the required amount is the size of a cherry or walnut, or 2 to 4 grams of the gel. Do not use more than 8 grams of the gel daily.

Elderly patients

No specific dose adjustment is necessary. If you are elderly, you should pay close attention to side effects and, if necessary, consult a doctor or pharmacist.

How to apply

Before using for the first time, unseal the tube. Do not use if seal is broken.

Diclak 12 hours is intended for application to the skin (must be used only on the skin).

Apply the gel to the affected parts of the body in a thin layer and gently rub into the skin.

After use, dry your hands with a cotton cloth or absorbent paper and then wash your hands if the treated area is not your hands.

Diklak 12 hours can be used with non-occlusive dressings, but should not be used with occlusive dressings that stop the access of air.

Duration of use

The duration of use depends on the symptoms and the underlying disease. Contact your doctor if the pain or inflammation does not improve or worsens within 7 days.

Adults (over 18 years)

Diclak 12 hours should not be used for longer than 14 days for the treatment of muscle, tendon and connective tissue injuries and 21 days for the treatment of arthritis without medical advice.

Juniors (under 18, 14 and over)

Diklak 12 hours should not be used for longer than 7 days without medical consultation. Longer treatment can only be recommended by your doctor.

If you use more than the required amount of Diklak 12 hours

An overdose is unlikely if you use more than the required amount of Diklak 12h, as a small amount is absorbed into the bloodstream when applied to the skin.

If the recommended dose is significantly exceeded when used on the skin, the gel should be removed and washed with water.

If you accidentally swallow this medicine, contact your doctor immediately.

If you forget to use Diklak 12 hours

If you miss a dose, take it as soon as you remember. Do not use a double dose to make up for a missed dose.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some rare and very rare side effects can be serious.

If you notice any of the following signs of allergy, stop using Diklak for 12 hours and immediately inform a doctor or pharmacist:

Skin rash with blistering; hives (rare: may affect up to 1 in 1,000 people)

Wheezing, shortness of breath or chest tightness (asthma) (very rare: may affect up to 1 in 10,000 people)

Swelling of the face, lips, tongue or throat (very rare: may affect up to 1 in 10,000 people)

Other side effects are possible:

Common side effects (may affect up to 1 in 10 people):

Skin rash, itching, redness, eczema, dermatitis (inflammation of the skin), including contact dermatitis.

Very rare side effects (may affect up to 1 in 10,000 people)

Pustular rash

Hypersensitivity reactions (including hives)

Sensitivity to light with the appearance of skin reactions after exposure to sunlight

When Diklak 12h is applied to large areas of skin and for a prolonged period, the possibility of systemic side effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) cannot be completely excluded, as it is likely they occur after systemic administration of drugs containing diclofenac,

5. How to store Diklak 12 hours

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the tube after 'EXP' 4. The expiration date corresponds to the last day of the specified month.

To be stored below 25°C. Do not refrigerate or freeze.

Do not use this medicine if you notice visible signs of deterioration.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Diclak 12 hours contains

The active substance is diclofenac diethylamine.

The other ingredients are: propylene glycol, oleyl alcohol, isopropyl alcohol, butylhydroxytoluene, diethylamine, paraffin, light liquid, macrogolcetostearyl ether, carbomer, cocoylcaprylocaprate, perfume cream and purified water.

What Diklak 12 hours looks like and what the pack contains

Diklak 12 hours is a viscous white gel with a characteristic aroma.

The gel is packed in an aluminum laminated tube with an HDPE ring, sealed with a slip and a polypropylene cap.

Types of packaging: tubes of 50 g, 100 g, 150 g and 180 g.

Not all types of packaging can be put on sale.